HESS: The Effects of Hydromorphone on Responses to Verbal Tasks

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02205983
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 4
• Actual Duration (Months): 20
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

In this study, the investigators will examine the effects of hydromorphone, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. The investigators have recently shown that buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will reduce both physiological and subjective measures of stress.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 2 mg hydromorphone; Drug: 1000 mg Acetaminophen; Drug: 4 mg hydromorphone; Drug: dextrose	N/A

Detailed Description

Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg hydromorphone, or placebo at each of two sessions; one during which they well participate in a stressful speaking task, and one during which they'll participate in a nonstressful control task. Physiological and subjective measures will be taken throughout each session.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effects of Hydromorphone on Responses to Verbal Tasks
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 mg hydromophone Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.	Drug: 2 mg hydromorphone; We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Experimental: 4 mg hydromphone Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion	Drug: 4 mg hydromorphone; We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Experimental: 1000 mg acetaminophen Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.	Drug: 1000 mg Acetaminophen; We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
Placebo Comparator: Dextrose Healthy adult volunteers will recieve Dextrose (placebo).	Drug: dextrose; We are administering dextrose to healthy volunteers for our placebo group.

Outcome Measures

Primary Outcome Measures

1. Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire [End of study (time 0 and approximately 4 weeks later), week 4 reported.]

   The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adult volunteers

Exclusion Criteria:

1. any current medical condition requiring medication or abnormal electrocardiogram

2. current or past medical condition considered to be a contraindication for the study conditions

3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis

4. less than high school education

5. lack of fluency in English

6. night shift work

7. Pregnancy, lactation or plans to become pregnant.

8. Use of hormonal contraception.

9. Daily cigarette smokers i.e., >7 cigarettes per week

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Hospital	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Harriet de Wit, PhD, University of Chicago
• Study Chair: Jerome Jaffe, MD, University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02205983
• Other Study ID Numbers: UC13-1027; R01DA002812
• First Posted: Aug 1, 2014
• Last Update Posted: Oct 9, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by University of Chicago: enrolling; adult; volunteers
• Additional relevant MeSH terms: Acetaminophen; Hydromorphone

Study Results

Participant Flow

Pre-assignment Detail	Participants were excluded if they had a serious medical condition, abnormal electrocardiogram, Axis I psychiatric disorder in the past year, or a history of psychosis. Subjects were also excluded if they had not completed high school, were not fluent in English, worked a night shift, used hormonal contraceptives, or were pregnant.

Arm/Group Title	2 mg Hydromorphone	4 mg Hydromorphone	1000 mg Acetaminophen	Dextrose (Placebo)
Arm/Group Description
Period Title: Overall Study
STARTED	12	12	13	13
COMPLETED	12	12	13	13
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	2 mg Hydromophone	4 mg Hydromorphone	1000 mg Acetaminophen	Dextrose (Placebo)	Total
Arm/Group Description	Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.	Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion	Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.	Healthy adult volunteers will receive Dextrose (placebo).	Total of all reporting groups
Overall Participants	12	12	13	13	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.9 (1.8)	21.2 (2.8)	23.6 (6.6)	23.1 (4.4)	22 (4.5)
Sex: Female, Male (Count of Participants)
Female	4 33.3%	4 33.3%	6 46.2%	5 38.5%	19 38%
Male	8 66.7%	8 66.7%	7 53.8%	8 61.5%	31 62%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	13 100%	13 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
Description	The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4
Time Frame	End of study (time 0 and approximately 4 weeks later), week 4 reported.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 mg Hydromophone	4 mg Hydromphone	1000 mg Acetaminophen	Dextrose
Arm/Group Description	Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion. 2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.	Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion 4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.	Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion. 1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.	Healthy adult volunteers will recieve Dextrose (placebo). dextrose: We are administering dextrose to healthy volunteers for our placebo group.
Measure Participants	12	12	13	13
Feel Drug	7.41 (1.2)	14.75 (1.9)	28 (1.5)	5.76 (1.1)
Like Drug	25.9 (1.8)	35.58 (2.5)	9.61 (2.2)	4.15 (1.4)
Feel High	6.08 (1.5)	10.33 (1.01)	15 (1.8)	2.61 (1.8)
Want More	8.0 (2.1)	26.83 (1.5)	7.38 (1.96)	2.65 (1.5)

Adverse Events

Arm/Group Title	2 mg Hydromophone		4 mg Hydromphone		1000 mg Acetaminophen		Dextrose
Arm/Group Description	Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion. 2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.		Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion 4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.		Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion. 1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.		Healthy adult volunteers will recieve Dextrose (placebo). dextrose: We are administering dextrose to healthy volunteers for our placebo group.
All Cause Mortality
	2 mg Hydromophone		4 mg Hydromphone		1000 mg Acetaminophen		Dextrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/13 (0%)		0/13 (0%)
Serious Adverse Events
	2 mg Hydromophone		4 mg Hydromphone		1000 mg Acetaminophen		Dextrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	2 mg Hydromophone		4 mg Hydromphone		1000 mg Acetaminophen		Dextrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/13 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.